In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.
|Articles|April 28, 2016
Montrium Adds eTMF Dashboard
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Montrium announced the global availability of its eTMF Navigator, an interactive dashboard integrated into its eTMF Connect. The eTMF Navigator offers users the ability to manage their ongoing studies directly in the navigator by updating artifacts, sites or country information and view the status to gain greater insight into clinical trial events and compliance. The eTMF Navigator also adds a dedicated inspector view for audits and inspections.
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The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.
Why clinical development’s next AI bottleneck is not the model, but the system around it.
In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.
FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines
The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.
A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.
Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.
This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.
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